KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED ON 10/07/2025: THE AR-2272 DRILL PIN BUTTON 3.7 MM WAS USED TO CREATE THE BONE TUNNEL, AND NO OTHER INSTRUMENT WAS USED. THE BONE QUALITY WAS REPORTED AS NORMAL.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B3, B5, G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER SURGICAL TECHNIQUE, SPECIFICALLY A FAILURE TO MAINTAIN ADEQUATE TENSION DURING IMPLANTATION.

Description of Event or Problem

ON 9/17/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL AN ISSUE INVOLVING THE AR-2372BLO KNOTLESS AC TIGHTROPE. DURING A PROCEDURE, THE SURGEON NOTED THAT WHEN TENSIONING THE TIGHTROPE, IT WOULD SLIDE BACK A FEW MILLIMETERS AND FAIL TO MAINTAIN THE INTENDED TENSION. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 09/22/2025: THIS EVENT OCCURRED DURING A CLAVICLE FX/ AC JOINT RECONSTRUCTION PROCEDURE ON (B)(6) 2025. THE ISSUE AROSE INTRAOPERATIVELY, RESULTING IN THE BUTTON REMAINING INSIDE THE PATIENT. NO PART OF THE IMPLANT BROKE DUE TO THE ISSUE. ALTHOUGH THE PROCEDURE WAS COMPLETED AS PLANNED, THE DESIRED TENSION WAS NOT ACHIEVED. AN AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT AND AN AR-2272 DRILL PIN BUTTON (3.7 MM) WERE UTILIZED TO COMPLETE THE CASE. THE TENSION WAS REATTEMPTED, CAUSING AN APPROXIMATE DELAY OF ONE MINUTE. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO PHOTOGRAPHS WERE TAKEN TO DOCUMENT THE EVENT.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.